New Delhi, April 13 (IANS) The Indian Council of Medical research has sought letters of intent from institutions with necessary equipment and infrastructure to participate in a clinical trial to study safety and efficacy of therapeutic plasma exchange in COVID-19 patients, subsequent to necessary approvals and clearances.
The apex medical research body's invite was uploaded on the ICMR website on Sunday.
The project is named “Multi-center, Phase II, Open Label, Randomized Controlled Study of Therapeutic Plasma Exchange in COVID-19”.
The Therapeutic Plasma Exchange (TPE) is an experimental procedure for critically ill COVID-19 patients which, the ICMR said, it does not recommend as a treatment option outside of clinical trials.
“Institutions interested to collaborate with ICMR on undertaking this trial intervention may express their interest by providing the details through the following link: https://forms.gle/7AaW528DMQbNZsUr9,” said the ICMR on its website, adding that hospitals and institutions planning to provide this modality of treatment should do so in a clinical trial with protocols which are cleared by the Institutional Ethics Committee.
The primary objective of the study is to assess the efficacy of TPE in improving the clinical status of COVID-19 patients and to evaluate the safety of treatment with anti SARS-CoV-2 plasma in patients with COVID-19.
The study will include hospitalised COVID-19 patients who are critically ill, fulfil the inclusion and exclusion criteria, and are admitted for care at COVID-19 management facilities in India.